[Congressional Record (Bound Edition), Volume 152 (2006), Part 18]
[Senate]
[Pages 23624-23625]
[From the U.S. Government Publishing Office, www.gpo.gov]




THE DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT

  Mr. ENZI. Mr. President, today Congress acted in the interest of the 
public health by passing the Dietary Supplement and Nonprescription 
Drug Consumer Protection Act. I am extremely pleased that the House has 
now passed this bill and sent it to the White House for the President's 
signature. This legislation would require manufacturers of dietary 
supplements and all manufacturers of over-the-counter drugs to report 
serious adverse events to FDA.
  The Dietary Supplement Health and Education Act of 1994, DSHEA 
ensures that a broad array of dietary supplements are available to 
American consumers. DSHEA protects consumer choice and access to 
dietary supplements that are safe and properly labeled.
  This bill will preserve the safety and availability of dietary 
supplements that benefit so many Americans. Although many dietary 
supplement manufacturers already give FDA reports they may receive 
regarding adverse events associated with their products, they are not 
required to do so. This legislation would add that requirement, while 
keeping safe supplements available to consumers.
  This proposal adds a new reporting requirement for dietary 
supplements and all manufacturers of over-the-counter, OTC, drugs to 
report serious adverse events to FDA. This is an entirely new 
requirement for supplements. Some OTC drug manufacturers are already 
required to report serious adverse events.
  The reporting would be limited to serious adverse events. We are 
talking about the kind of information FDA really needs--reports of 
death, a life-threatening experience, hospitalization, a persistent or 
significant disability or incapacity, or a congenital anomaly or birth 
defect.
  To ensure that unscrupulous competitors cannot damage legitimate 
businesses, the bill makes it a prohibited act to make a deliberately 
false adverse event report to a manufacturer or to the FDA.
  The bill also sets a 15-day time limit for manufacturers to turn over 
reports of serious adverse events they receive. They must keep the 
reports for 6 years, and FDA is allowed to inspect the manufacturer's 
records of adverse event reports.
  This new Federal requirement would replace any potential state 
requirements. However, States would still work with FDA on safety 
issues.
  And safety is what this bill is all about. You need good data to make 
good decisions. Most dietary supplements are safe and should be 
available to consumers. But just in case one isn't, FDA needs to have 
accurate, current information to decide when to act and what to do. 
This bill will help the agency get that information.
  This bill is the result of a tremendous amount of work across party 
lines. I want to thank my colleagues

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Senators Hatch and Harkin here on the committee, and Senator Durbin, 
for getting this bill started. I would also like to express my deep 
appreciation and thanks to the ranking member, Senator Kennedy, for his 
hard work during this process. We have produced a fair bill, and I am 
so pleased my colleagues on both sides of the Capitol have lent it 
their support.

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